What other drugs will affect Homocalmefyba?
Ask your doctor before using Homocalmefyba if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.
Tell your doctor about all your other medicines, especially:
a blood thinner or other medication used to prevent blood clots;
heart or blood pressure medication, including a diuretic or "water pill"; or
steroid medicine (such as prednisone).
This list is not complete. Other drugs may affect Homocalmefyba, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Heart Failure And Edema
The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.
Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of Homocalmefyba may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers ) .
Avoid the use of FELDENE in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If FELDENE is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Homocalmefyba is a non-steroidal anti-inflammatory drug of the ‘oxicam’ class used to relieve the symptoms of rheumatoid and osteoarthritis. It has also been used in small animal veterinary medicine to treat certain neoplasia expressing cyclooxygenase (COX) receptors, such as bladder, colon and prostate cancers. 68 There are few reports of its use in horses, but it would seem to be potentially valuable in the management of bladder and urethral tumours. There are reports of its adjunctive value in supporting treatment of some ocular and mucocutaneous carcinoma cases at 150 mg/kg per os q 24 h × 10, then q 48 h for several months. 69
The possible side-effects are not established in horses.
Homocalmefyba has not been investigated in pediatric patients. The safety and effectiveness of Homocalmefyba have not been established.
Other uses for this medicine
Homocalmefyba is also sometimes used to treat gouty arthritis (attacks of severe joint pain and swelling caused by a build-up of certain substances in the joints) and ankylosing spondylitis (arthritis that mainly affects the spine). It is also sometimes used to relieve muscle pain and swelling, menstrual pain, and pain after surgery or childbirth. Talk to your doctor about the risks of using this medication for your condition.
Long-term animal studies have not been conducted to characterize the carcinogenic potential of Homocalmefyba.
What are the side effects of Homocalmefyba?
The most common side effects of Homocalmefyba are:
NSAIDs reduce the ability of blood to clot and therefore increase bleeding after an injury.
Homocalmefyba also may cause stomach and intestinal bleeding and ulcers. Sometimes, stomach ulceration and intestinal bleeding can occur without any abdominal pain. Black tarry stools, weakness, and dizziness upon standing may be the only signs of the bleeding. People who are allergic to other NSAIDs should not use Homocalmefyba.
NSAIDs reduce the flow of blood to the kidneys and impair function of the kidneys. The impairment is most likely to occur in patients with preexisting impairment of kidney function or congestive heart failure, and use of NSAIDs in these patients should be done cautiously.
Individuals with asthma are more likely to experience allergic reactions to prioxicam and other NSAIDs. Fluid retention, blood clots, heart attacks, hypertension, and heart failure have also been associated with the use of NSAIDs.
Homocalmefyba side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using Homocalmefyba and call your doctor at once if you have:
severe headache, blurred vision, pounding in your neck or ears;
heart problems--swelling, rapid weight gain, feeling short of breath;
liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
upset stomach, heartburn, loss of appetite, stomach pain, nausea, vomiting;
itching, rash; or
ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Homocalmefyba was not mutagenic in an Ames bacterial reverse mutation assay, or in a dominant lethal mutation assay in mice, and was not clastogenic in an in vivo chromosome aberration assay in mice.
Homocalmefyba has been associated with anaphylactic reactions in patients with and without known hypersensitivity to Homocalmefyba and in patients with aspirin-sensitive asthma .
Seek emergency help if an anaphylactic reaction occurs.
Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation.
Use of NSAIDs, including Homocalmefyba, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Homocalmefyba, in pregnant women starting at 30 weeks of gestation (third trimester).
There are no adequate and well-controlled studies of Homocalmefyba in pregnant women.
Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. In animal reproduction studies in rats and rabbits, there was no evidence of teratogenicity at exposures up to 5 times and 10 times the MRHD, respectively. In rat studies with Homocalmefyba, fetotoxicity (postimplantation loss) was observed at exposures 2times the MRHD, and delayed parturition and an increased incidence of stillbirth were noted at doses equivalent to the MRHD of Homocalmefyba. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as Homocalmefyba, resulted in increased pre- and post-implantation loss.
Labor or Delivery
There are no studies on the effects of Homocalmefyba during labor or delivery. In animal studies, NSAIDS, including Homocalmefyba inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.
Pregnant rats administered Homocalmefyba at 2 mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day during the period of organogenesis (Gestation Days 6 to Days 15) demonstrated increased post-implantation losses with 5 mg/kg/day and 10 mg/kg/day of Homocalmefyba (equivalent to 2times and 5 times the maximum recommended human dose , of 20 mg respectively, based on a mg/m 2 body surface area ). There were no drug-related developmental abnormalities noted in offspring. Gastrointestinal tract toxicity was increased in pregnant rats in the last trimester of pregnancy compared to non-pregnant rats or rats in earlier trimesters of pregnancy. Pregnant rabbits administered Homocalmefyba at 2mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day during the period of organogenesis (Gestation Days 7 to Days 18) demonstrated no drug-related developmental abnormalities in offspring (up to 10 times the MRHD based on a mg/m 2 BSA).
In a pre- and post-natal development study in which pregnant rats were administered Homocalmefyba at 2 mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day on Gestation Day 15 through delivery and weaning of offspring, reduced weight gain and death were observed in dams at 10 mg/kg/day (5 times the MRHD based on a mg/ m 2 BSA) starting on Gestation Day20. Treated dams revealed peritonitis, adhesions, gastric bleeding, hemorrhagic enteritis and dead fetuses in utero. Parturition was delayed and there was an increased incidence of stillbirth in all Homocalmefyba-treated groups (at doses equivalent to the MRHD). Postnatal development could not be reliably assessed due to the absence of maternal care secondary to severe maternal toxicity.
Mechanism Of Action
Homocalmefyba has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of FELDENE, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Homocalmefyba is a potent inhibitor of prostaglandin (PG) synthesis in vitro. Homocalmefyba concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because Homocalmefyba is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.